MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION OVERPRESSURE SAFETY VALVE; VALVE, O.P.S (STERILE) FOR TC

Model Number LH130J

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/24/2015

Event Type  malfunction  

Manufacturer Narrative

Visual inspection was performed on the actual sample upon receipt, during which no anomalies were found anywhere on the device.The actual sample was pressure and flow tested by pressurizing with air and submerging the sample into a water bath.The unit was confirmed to properly allow forward flow within specification.Four additional flow and leak tests were performed on the sample to challenge each component within the valve.All tests passed within product specification.The reported issue was not able to be confirmed and a definitive root cause was not able to be determined.(b)(4).Unable to confirm complaint.

Event Description

The user facility reported to terumo cardiovascular systems corporation that during cardiopulmonary bypass the suctioning flow of two overpressure safety valves was slower than usual.The issue occurred on the two devices in succession.This event was initially deemed not reportable on (b)(6) 2015; however, terumo has issued a voluntary safety alert, (b)(4) on (b)(6) 2017.This event has become associated with the safety alert and has since become reportable.*no known impact or consequence to patient.*product was changed out.*surgery was completed successfully.

Manufacturer Narrative

(b)(4).The investigation results and conclusions, previously reported, remain the same.

Event Description

(b)(4).

• Brand Name: OVERPRESSURE SAFETY VALVE
• Type of Device: VALVE, O.P.S (STERILE) FOR TC
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 6695102
• MDR Text Key: 79522991
• Report Number: 1124841-2017-00128
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LH130J
• Device Lot Number: UNKNOWN
• Other Device ID Number: (01)00699753450233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2017
• Initial Date FDA Received: 07/07/2017
• Supplement Dates Manufacturer Received: 12/01/2017
• Supplement Dates FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1124841-06/25/2017-001-R
• Patient Sequence Number: 1